AstraZeneca
AssociatePrincipalScientist(Analytical)
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“Associate Principal Scientist (Analytical) at AstraZeneca. Skills: Analytical Sciences, Pharmaceutical Industry, Drug Development, Commercialization Process. Provide expert technical support to commercial products. Maintain skills in assigned core capabilities”
What You'll Achieve.
Ensure that all work is carried out in compliance with AstraZeneca and external regulatory policies and standards; Operate at the highest level of risk management; Conduct activities and interactions consistent with Company values; Complete all required training on the AZ Code of Ethics and supporting Policies and Standards on time; Report potential issues of non-compliance; Significant impact on the overall success of Operations; Ensuring the commercial viability of current products; Ensure availability of all AstraZeneca products to the commercial organization; Significant impact on both financial and reputational aspects of the business
Industry & Context.
Technical problem-solving expertise; Develop solutions to a diverse range of problems requiring complex judgements
What They're Looking For.
Must Have
Good understanding of the overall drug development and commercialization process, At least 5-10 years of experience relevant to the pharmaceutical industry, Professional credibility within the business and industry, In-depth understanding of analytical sciences in the Pharmaceutical Industry, Thorough understanding of principles, applications and management of SHE and cGMP, Business acumen
Nice to Have
Experience in or exposure to multiple disciplines in CMC and related functions, In depth understanding of multiple disciplines, such as (besides analytical) formulation, packaging, automation, validation
What You'll Do.
Provide expert technical support to commercial products
Maintain skills in assigned core capabilities
Management of product knowledge throughout the lifecycle
Maintain technical knowledge in area of subject matter expertise
Regulatory file authoring
license renewals and response to questions
Provision of technical leadership to support product supply strategy projects
Responsible for the technical support during the transfer of established products
Support complex technical improvements or change activities
Support for drug product PPQ programs
Provision of technical problem-solving expertise
Assist in the development of CAPAs
Responsible expert for a commercial product
Responsible for analytical lifecycle activities
Leads the review of analytical methods performance
Supports the definition of analytical standards
Provides training in subject matter expertise areas
May be the product lead for one or more products
Executes Technical leadership and influencing
Develops and manage a prioritized portfolio of TOSI project activities
Ensures effective collaboration between PT&D and sites
Maintains a technical support model
Builds effective networks across the Global Operations organisation
Leads and assess impact of complex technical improvements
Develop solutions to a diverse range of problems
Provides Technical leadership to Issue Management Team
Project resource estimations to support the budgeting process
How You'll Work.
Team & Collaboration
Create an effective partnership; Manage expectations; Resolve issues positively; Be an excellent communicator with interpersonal skills; Collaborate effectively with stakeholders; Ensures effective collaboration between PT&D and the AZ sites/External Supply Management (ESM) managed sites/QC laboratories and Global Partners; Builds effective networks across the Global Operations organisation and with the R&D functions; Executes Technical leadership and influencing in Pharmaceutical Teams and within TOSI
Communication Scope
Excellent communicator with interpersonal skills
Process & Methodology
Develops and manage a prioritized portfolio of TOSI project activities, Project resource estimations to support the budgeting process
Full Job Description
The role holder is responsible for providing expert technical support to commercial products manufactured internally at AZ sites and externally at contract facilities. This job description is relevant for on-market technical leaders whose subject matter expertise supports input for **Analytical Sciences.** These leadership roles will not have direct reports. General Responsibilities include: * Maintaining skills in assigned core capabilities for example, but not limited to, documentation practices, quality and regulatory compliance, data integrity, change management, GPM, lean capabilities & product security. * Management of product knowledge throughout the lifecycle. * Maintain technical knowledge in area of subject matter expertise including up to date advances in new regulations and technologies to aid in the improvement of pharmaceutical processes and or analytical methods. * Regulatory file authoring, review, license renewals and response to questions. * Provision of technical leadership to support product supply strategy projects (sourcing, asset transfers, capacity expansion, etc.) and business continuity plans through delivery of the drug product control strategy, and product quality risk management activities throughout the lifecycle. * Responsible for the technical support during the transfer of established products within sites and to external manufacturing partners including support for equivalency determination as applicable. * Support complex technical improvements or change activities assuring product performance and analytical methods robustness, including extractables and leachable assessments, nitrosamines risk assessments and risk assessments of elemental and organic impurities. * Support for drug product PPQ programs in the support of transfer and change activities. * Provision of technical problem-solving expertise to aid in the resolution of manufacturing/method/formulation issues & complaints impacting supply or manufacturability. * Assist in
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